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Inivata Begins Testing Lung Cancer Patients in ALKALINE Trial

NEW YORK – Liquid biopsy testing firm Inivata said on Wednesday that it has molecularly profiled the first lung cancer patients using its InVisionFirst-Lung ctDNA panel within the Phase II ALKALINE trial of lorlatinib (Pfizer's Lorviqua in Europe and Lobrena in the US).

In the study, launched in 2019 by the European Organization for Research and Treatment of Cancer, researchers plan to enroll 100 patients with ALK-positive non-small cell lung cancer and assess their outcomes on lorlatinib. Patients must have progressed on a second-generation ALK inhibitor, have ALK rearrangements detected by a US Food and Drug Administration-approved fluorescence in situ hybridization or immunohistochemistry test, and provide blood samples for further testing by Inivata's liquid biopsy assay to improve understanding of resistance mechanisms. 

Lorlatinib is already approved in the US and Europe for advanced ALK-positive NSCLC patients after they have stopped responding to other ALK inhibitors, such as alecitnib (Genentech's Alecensa), ceritinib (Novartis' Zykadia), and crizotinib (Pfizer's Xalkori).

According to Inivata, its InVisionFirst-Lung test, a 36-gene ctDNA next-generation sequencing panel, will be used to determine lung cancer patients' ALK mutational profile and determine if that blood-based mutational profile is associated with their 12-month outcomes with lorlatinib. The test will also be administered to patients when they progress on lorlatinib to look for new ALK mutations or other molecular mechanisms that may be contributing to resistance.

"It is of vital importance that clinicians gain a better understanding of the patterns of resistance to drug therapies in cancer treatment, where time is of the essence in ensuring the best outcomes for patients," Laura Mezquita from the Hospital Clinic in Barcelona, who is co-principal investigator of ALKALINE, said in a statement. "We hope that this study will not only provide insights on how to adjust existing treatment regimens to make them more effective for patients, but could also assist in the development of combination treatments, which would prevent this build-up of resistance in the first place."

In a sub-study, researchers will use InVisionFirst-Lung to determine when patients develop molecular resistance to second-generation TKIs through the emergence of ALK mutations and other resistance mechanisms, and evaluate the utility of liquid biopsy monitoring.